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Guidance (MQSA)

Guidance (MQSA)

New Format for the PGHS

Due to changes in the Food and Drug Administration web site, the MQSA Program has been asked to re-format the Program's widely-used Policy Guidance Help System (PGHS). Since its inception in the 1990's, the PGHS has been the repository of all guidance issued by the Division of Mammography Quality Standards, consolidated in one place for easy reference by the entire mammography community and consumers.

The PGHS in its new format will be made available on the FDA's MQSA web site. The new format has advantages over the current, web-based format: it has an index, it's searchable, and it has a glossary. Also, the entire PGHS can be downloaded in an easy-to-use Compiled HTML Help File format; this Help File version is small in size, so it can be easily downloaded over the slowest Internet connection. However, you must have WinZip or equivalent software to decompress the downloaded file.

We have corrected some transcription errors which were pointed out to us by users of the PGHS; however, the policy content is unchanged.

Draft and Approved Guidance

FDA follows its Good Guidance Practice’s protocol when issuing guidance. Guidance is developed in response to questions we receive from the mammography community, patients and other interested parties. FDA issues guidance as either draft or final. Draft guidance is issued when the matter being addressed is new, complicated or controversial. Draft guidance is published for public comment and is issued as final only after the public’s comments are considered. Guidance is issued as final if it not new, complicated or controversial or has already gone through the draft process.

Drafts of proposed guidance currently open for public comment will be provided in the section below. Final guidance documents may be accessed by clicking on Final Guidance. Final Guidance is also incorporated into the Policy Guidance Help System. Guidance in the Policy Guidance Help System represents FDA's current thinking on the MQSA final regulations.

Other Guidance Documents

Documents that provide additional assistance in complying with MQSA requirements include: